Abstract
BackgroundYouth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this.ObjectiveThis study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al.MethodsThis study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives.ResultsData collection for this study is projected to begin in August 2018 and last until June 2020.ConclusionsThis is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs.Trial RegistrationClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z)International Registered Report Identifier (IRRID)PRR1-10.2196/11183
Highlights
Adherence to Antiretroviral Therapy in Youth Living With HIVAdherence to antiretroviral therapy (ART) is a critical factor contributing to low rates of viral suppression among youth living with HIV
We expect that data based on Sequential Multiple Assignment Randomized Trial (SMART) design will yield valuable information for hypotheses generation, involving high-quality embedded interventions, which can guide the design of subsequent confirmatory studies
JMIR Res Protoc 2018 | vol 7 | iss. 12 | e11183 | p. 10 beyond what has been done previously in several key ways: (1) it directly compares 2 successful, potentially sustainable, and youth-friendly modes of Mobile health (mHealth) youth adherence intervention delivery; (2) the project uses a SMART design to explore a number of key issues surrounding sequencing mHealth interventions in a cost-effective manner that would be practical in clinical settings; (3) the CPS intervention uniquely addresses multiple barriers to ART adherence in real time using a social support framework; and (4) the study explores the clinical and public health costs of sequencing of interventions based on viral suppression and sexual transmission risk
Summary
Adherence to antiretroviral therapy (ART) is a critical factor contributing to low rates of viral suppression among youth living with HIV. Objective: This study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined This protocol is part of the ATN Scale It Up program described in this issue by Naar et al Methods: This study uses a Sequential Multiple Assignment Randomized Trial design. Trial Registration: ClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z) International Registered Report Identifier (IRRID): PRR1-10.2196/11183
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